Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 31941–31960 of 38,428 recalls
Recalled Item: AMS Monarc + Subfascial Hammock with Tensioning Suture
The Issue: During routine periodic packaging testing, AMS identified that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AdVance"Male Sling System
The Issue: During routine periodic packaging testing, AMS identified that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AlignRT- Intended for prescription use. The system is indicated for
The Issue: failure of AlignRT to assert interlock
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATTUNE Intuition Distal Femoral Jig
The Issue: Issuing a device correction because if the pin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial
The Issue: To provide clarifying instructions relating to the assembly/disassembly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trabecular Metal Tibial Impactor. Product Usage: TM Tibial Impactor pads
The Issue: To provide clarifying instructions relating to the assembly/disassembly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery NM 630
The Issue: GE is updating the Preventative Maintenance procedure and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging...
The Issue: GE is issuing this recall due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optima NM/CT 640
The Issue: GE is issuing this recall due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brivo NM615
The Issue: GE is issuing this recall due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Infinia (including Infinia
The Issue: GE is issuing this recall due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA
The Issue: GE is issuing this recall due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: St. Jude Medical
The Issue: St. Jude Medical is performing a voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: St Jude Medical
The Issue: St. Jude Medical is conducting a voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Launcher Coronary Guide Catheter
The Issue: Two reports have been received on the 6F
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable
The Issue: Several complaints regarding the IV sets leaking at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gel-E Donut : 92025-A (Extra Small)
The Issue: Mold on gel filled Gel-E and Squishon products
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Transport Chair and Rollator in 1
The Issue: Silver Star Brands is recalling the Transport Chair
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens SimView NT and SimView NT with IDI simulation system
The Issue: Siemens became aware of a very rare occurrence
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700
The Issue: AMS' supplier has issued a recall of certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.